Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-28 @ 3:26 AM
Study NCT ID:
NCT01431235
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2011-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-13', 'studyFirstSubmitDate': '2011-09-08', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'self reported ADHD symptoms', 'timeFrame': '6 months', 'description': 'Dutch self report list of ADHD symptoms by Kooij and Buitelaar'}], 'secondaryOutcomes': [{'measure': 'Time Line Follow Back method', 'timeFrame': '6 months', 'description': 'self-reported alcohol and drug use'}, {'measure': 'Beck depression inventory', 'timeFrame': '6 months', 'description': 'self reported depression symptoms'}, {'measure': 'Beck Anxiety Inventory', 'timeFrame': '6 months', 'description': 'Self reported anxiety symptoms'}, {'measure': 'EQ-5', 'timeFrame': '6 months', 'description': 'Self reported quality of living'}, {'measure': 'TIC-P', 'timeFrame': '6 months', 'description': 'health care consumption and production loss in relation to mental health problems'}, {'measure': 'Stroop task', 'timeFrame': '6 months', 'description': 'neuropsychological measure'}, {'measure': 'Tower of London task', 'timeFrame': '6 months', 'description': 'neuropsychological task'}, {'measure': 'BART task', 'timeFrame': '6 months', 'description': 'neuropsychological task on risk taking behavior'}, {'measure': 'urine checks', 'timeFrame': '6 months', 'description': 'urine checks on drug use'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD', 'SUD', 'cognitive behavioral therapy'], 'conditions': ['Attention Deficit Hyperactivity Disorder', 'Substance Use Disorders']}, 'referencesModule': {'references': [{'pmid': '18558465', 'type': 'BACKGROUND', 'citation': 'Arias AJ, Gelernter J, Chan G, Weiss RD, Brady KT, Farrer L, Kranzler HR. Correlates of co-occurring ADHD in drug-dependent subjects: prevalence and features of substance dependence and psychiatric disorders. Addict Behav. 2008 Sep;33(9):1199-207. doi: 10.1016/j.addbeh.2008.05.003. Epub 2008 May 13.'}, {'pmid': '21254791', 'type': 'BACKGROUND', 'citation': 'Castells X, Ramos-Quiroga JA, Rigau D, Bosch R, Nogueira M, Vidal X, Casas M. Efficacy of methylphenidate for adults with attention-deficit hyperactivity disorder: a meta-regression analysis. CNS Drugs. 2011 Feb;25(2):157-69. doi: 10.2165/11539440-000000000-00000.'}, {'pmid': '20736471', 'type': 'BACKGROUND', 'citation': 'Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.'}, {'pmid': '20231319', 'type': 'BACKGROUND', 'citation': 'Solanto MV, Marks DJ, Wasserstein J, Mitchell K, Abikoff H, Alvir JM, Kofman MD. Efficacy of meta-cognitive therapy for adult ADHD. Am J Psychiatry. 2010 Aug;167(8):958-68. doi: 10.1176/appi.ajp.2009.09081123. Epub 2010 Mar 15.'}, {'pmid': '23663651', 'type': 'DERIVED', 'citation': 'van Emmerik-van Oortmerssen K, Vedel E, Koeter MW, de Bruijn K, Dekker JJ, van den Brink W, Schoevers RA. Investigating the efficacy of integrated cognitive behavioral therapy for adult treatment seeking substance use disorder patients with comorbid ADHD: study protocol of a randomized controlled trial. BMC Psychiatry. 2013 May 10;13:132. doi: 10.1186/1471-244X-13-132.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.', 'detailedDescription': 'Attention Deficit Hyperactivity Disorder(ADHD) is an important comorbid condition in patients with substance use disorders (SUD). The prevalence of ADHD in patients with SUD is estimated 23%, and ADHD is associated with an untoward prognosis of SUD. However, adequate treatment programs for patients with ADHD and SUD are not available. Results of medication trials for patients with ADHD and SUD are disappointing, and cognitive behavioral therapy (CBT) has not yet been investigated in this population. In patients with ADHD without comorbid SUD, the results of CBT in randomized trials are positive. The purpose of this study is to investigate if CBT is effective in treating ADHD symptoms in patients with ADHD and SUD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* substance use disorder\n* ADHD\n* able to comply with study activities\n\nExclusion Criteria:\n\n* severe neurological or psychiatric diseases (for example Parkinson, dementia, psychosis, bipolar depression) which require medication\n* unable to read or write Dutch language'}, 'identificationModule': {'nctId': 'NCT01431235', 'briefTitle': 'CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arkin'}, 'officialTitle': 'Investigating the Efficacy of Cognitive Behavioral Therapy in Patients With Substance Use Disorder and Comorbid ADHD. A Randomized Controlled Trial With Cognitive Behavioral Therapy', 'orgStudyIdInfo': {'id': '10-130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard addiction treatment', 'description': '10 sessions of standard addiction treatment. No ADHD treatment.'}, {'type': 'EXPERIMENTAL', 'label': 'addiction treatment and ADHD treatment', 'description': '10 sessions cognitive behavioral therapy on addiction treatment combined with 5 sessions on ADHD treatment.', 'interventionNames': ['Behavioral: cognitive behavioral therapy for treating ADHD symptoms']}], 'interventions': [{'name': 'cognitive behavioral therapy for treating ADHD symptoms', 'type': 'BEHAVIORAL', 'description': '5 sessions of one hour CBT for treating ADHD symptoms by a trained health care worker', 'armGroupLabels': ['addiction treatment and ADHD treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Arkin', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Robert Schoevers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arkin', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fonds NutsOhra', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}